Senior Product Specialist:Compliance & Quality for Regulated Industries-Digital Manufacturig (f/m/d)

In this role you define and drive a product strategy for SAP Digital Manufacturing within the Autonomous Enterprise, focusing on IT quality and compliance in regulated settings. You’ll shape quality strategies to meet GxP, 21 CFR Part 11, and GAMP requirements, collaborating with cross-functional teams to keep products compliant. You’ll lead validation concepts, continuous revalidation, and audits, while exploring AI-enabled improvements. This role blends product leadership with regulatory expertise to enable trusted manufacturing solutions.

• Own GxP QA in SDLC and related operations (change, risk, audit, supplier management)
• Support implementation and maintenance of the DM Validation Concept and required documentation
• Support design and implementation of continuous revalidation of DM
• Assist with supplier and customer audits and prepare necessary documents
• Translate ISO content into ISPE GAMP-compliant formats
• Continuously assess internal processes and solution capabilities for GxP and compliance
• Develop and deliver a product vision and roadmap for DM, including AI in regulated environments

• 4+ years in consulting, product engineering, or management of computerized system validation in regulated industries (Pharma, Life Sciences, Biotech, Medical Devices); SAP DM/MES validation preferred

• Analytical thinking
• Planning and coordination
• Strong written and verbal communication; ability to translate complex topics clearly
• FDA, GxP, 21 CFR Part 11/820, GAMP knowledge
• Software validation and go-live procedures
• Process or discrete manufacturing experience in ERP/MES; SAP DM or related SAP products a plus